Painzaway Balm
NDC Package 10578-040-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Painzaway Balm is adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult physician. Marketed by Indiana Botanic Gardens, this product is identified by NDC 10578-040 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
10578-040-01
Package Description
29 g in 1 JAR
Product Code
10578-040
11-Digit Billing Format
10578004001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Painzaway Balm
Dosage Form
-
Usage Information
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult physician.

Regulatory & Marketing

Labeler Name
Indiana Botanic Gardens
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
12-01-2001
Listing Expiration
12-31-2019
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10578-040). Click a package code to view its specific billing and regulatory data.

10578-040-02
57 g in 1 JAR

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10578-040-01 identifies a specific commercial package of 29 g in 1 jar of Painzaway Balm, labeled by Indiana Botanic Gardens. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Indiana Botanic Gardens on December 01, 2001. The current certification is valid through December 31, 2019.

How is this Indiana Botanic Gardens product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10578004001. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
10578-040-01
11-Digit CMS (5-4-2)
10578-0040-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.